PATIENTS. This study was carried out in two parts. In the first part, 102 post-prostatic massage urine samples were collected from patients with known prostate cancer (38 patients) and controls (64 patients, with normal digital rectal examination and serum prostate-specific antigen

RESULTS. In the first part of the study, the best cut-off for the PCA3 ratio (defined as the ratio of the Ct value of PCA3/PSA mRNA) was 1.127. Applying this cut-off to the 47 patients with clinically suspected prostate cancer and no history of previous prostate biopsy, the sensitivity and specificity of PCA3 for diagnosing prostate cancer were 71% and 92%, respectively.